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MEBEVERINE
MEBEVERINE is a mebeverine drug. It is currently in Phase 3 development for Irritable bowel syndrome.
Mebeverine is a small molecule used to treat conditions such as Irritable Bowel Syndrome (IBS) and Portal Hypertension. It has been studied in clinical trials in combination with other interventions, including Ebastine and Peppermint Oil, for the treatment of IBS.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | MEBEVERINE |
|---|---|
| Drug class | mebeverine |
| Modality | Small molecule |
| Therapeutic area | Gastroenterology |
| Phase | Phase 3 |
Approved indications
- Irritable bowel syndrome
Common side effects
- Headache
- Nausea
- Asthenia
Key clinical trials
- Ebastine Versus Mebeverine in IBS Patients (PHASE3)
- Efficacy and Safety of Mebeverine + Simethicone in Patients With Functional Bowel Disorders (PHASE3)
- Enteric-Coated Peppermint Oil Versus Standard Antispasmodic in SLC6A4 (5-HTTLPR) Carriers With Irritable Bowel Syndrome. (NA)
- The Instant Efficacy and Safety of Alverine in Decreasing Portal Hypertension: an Exploratory Pilot Study (PHASE2)
- Carvedilol and Alverine in Portal Hypertension (PHASE2,PHASE3)
- The Safety and Efficacy of Alverine in the Treatment of Cirrhotic Portal Hypertension (PHASE2,PHASE3)
- The Efficacy and Safety of Alverine in the Treatment of Portal Hypertension in Patients With Liver Cirrhosis (PHASE2,PHASE3)
- To Compare the Efficacy of Drugs in Combination for Treating Irritable Bowel Syndrome Associated With Diarrhea (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- MEBEVERINE CI brief — competitive landscape report
- MEBEVERINE updates RSS · CI watch RSS
Frequently asked questions about MEBEVERINE
What is MEBEVERINE?
What is MEBEVERINE used for?
What drug class is MEBEVERINE in?
What development phase is MEBEVERINE in?
What are the side effects of MEBEVERINE?
Related
- Drug class: All mebeverine drugs
- Therapeutic area: All drugs in Gastroenterology
- Indication: Drugs for Irritable bowel syndrome
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing